Rocket Pharmaceuticals voluntarily withdrew its biologics license application with the FDA for its Fanconi anemia gene therapy RP-L102, following a corporate restructuring and prioritization of cardiovascular programs. The company cited business and strategic considerations rather than safety or efficacy concerns. This withdrawal preserves Rocket's ability to reengage with regulators if suitable partnership opportunities arise. The decision comes amid regulatory challenges for Rocket, including a prior FDA denial for another gene therapy and a clinical hold in a separate rare-disease trial.